Ensuring quality of products and services is a challenging venture for many companies. Applying basic aspects of quality management, including quality planning, control, assurance and improvement form the starting point. For companies in life sciences, healthcare and cosmetics industries, quality management is a comprehensive task. That’s why we offer support in various aspects of quality management.
Few sectors are exposed to risks more than life sciences and medical (devices) industries, issues with quality or patient safety can result in high human toll and legal claims. The purpose of a quality management system (QMS) for these companies is to bring their products or services onto the market in a safe, consistent and high-quality manner. This process consists of various types of quality-related activities:
Quality Planning: translation of the companies quality policy in tangible requirements, a roadmap to implement these within a specified timeframe and key process indicators to measure them
Quality assurance: prevention of errors in product manufacturing processes to ensure quality, for example via audits and tests during the process.
Quality control: detection of quality-related issues in products or services after manufacturing, for example via inspection.
Continuous improvement: continuous improvement processes are focused on ongoing improvement of products and processes, via continuous testing, evaluation and adjustment.
The International Organization for Standardization (ISO) governs the international standard for quality management systems: ISO 9001:2015. By applying this standard, companies can verify they are meeting quality requirements. Among others, ISO 9001 states that companies need to clearly understand customer requirements and that need to manage and continuously improve internal processes – like documentation, equipment, software, management, design and production – to meet quality requirements. ISO 9001:2015 is based on specific quality management principles:
The right processes will help companies to ensure optimal quality. It is of key importance to have an accurate, up-to-date document management system in place to make sure all process information is retraceable. In addition, a comprehensive training system ensures that all employees are informed and trained in a timely manner in the processes they are involved in as well as in changes to these processes.
A quality management system consists of following components:
Of course, the importance of quality of your products and services is a no-brainer. By keeping a close track on all important amendments in quality requirements and regulations, you will reinforce your company’s immune system and keep control of risks associated with quality and safety. In addition, quality management has an important purpose from a business perspective. Quality is good business sense and will increase the profitability of your business. Many constituent processes that you will build within your quality management system, also support customer satisfaction. If you combine this with insights on safety, supply chain and finance, you have a powerful instrument to help understand why your company misses out on deals or orders, and how to solve this problem.
The advantages of quality management are clear, but how do you set up a quality management system? Be aware of the fact that a quality management system needs to be supported by the entire organization of your company. And you need to make sure that it’s just right for your own business. Prevent implementation issues for your quality management system and make sure to create a thorough roadmap including the following steps:
There are two types of continuous or continual improvement in quality management. First, there is the gradual incremental improvement that helps you to deliver a better product in a consistent way. Secondly, there is the ‘breakthrough’ improvement. This means that you focus on major improvements in certain key areas to address issues radically and deliver a whole new level of product quality.
Our quality management experts help companies to guarantee full compliance of their products and/or services. In this quality management process, we always work according to a risk-based approach, focusing on what’s really important. And by working in a pragmatic, structured way and meticulously documenting every aspect, we guarantee optimal reliability of your quality management procedures.
Our balanced team of seniors, mediors and juniors helps you to set up or optimize your quality management processes. Our experts offer advice and support on validation, qualification and tech transfers. We assist large companies during their quality management for projects or the transformation of products, and help small companies work efficiently during production.
Are you planning to improve your quality management, but don’t know where to start? We are happy to advise and assist you during this process. With the right guidance and support – based on your specific needs – we set you up so that you will be able to manage your quality independently once we are finished.